Authors
Ogawa H, Nakayama M, Morimoto T, et al.
Title
Low-dose Aspirin for Primary Prevention of Atherosclerotic Events in Patients with Type 2 Diabetes
References
JAMA 2008;300:2134-2141.
Background
Patients with diabetes are at higher risk for cardiovascular events. Although antiplatelet therapy is clearly beneficial for secondary prevention, it is unclear whether is as useful for primary prevention in patients with diabetes.
Purpose
To determine the efficacy of low-dose aspirin for the primary prevention of atherosclerotic events in patients with type 2 diabetes.
Design
  • Prospective, randomized, open-label, controlled trial with blinded end-point analysis in Japan.
  • 2,539 patients, age 30-85 years, with diabetes (type 2) without a history of atherosclerotic disease
Exclusion Criteria
None.
Follow-Up
4.37 years (mean)
Treatment Regimen
  • Aspirin (81 or 100 mg/day) or;
  • Non-aspirin group (allowed to use antiplatelet/thrombotic therapy, if needed)
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Results
Primary endpoint: Any atherosclerotic event (sudden death; death from coronary, cerebrovascular, and aortic causes; nonfatal acute MI; unstable angina; newly developed exertional angina; nonfatal ischemic and hemorrhagic stroke; transient ischemic attack; or nonfatal aortic and peripheral vascular disease)

There was no significant difference in atherosclerotic event rate between the aspirin and non-aspirin group (13.6 per 1000 person-years vs 17.0 per 1000 person-years, p=0.16). The combined endpoint of fatal coronary events and fatal cerebrovascular events was lower in patients on aspirin (HR 0.10; CI 0.01-0.79; p=0.0037). All cause mortality, and the composite of hemorrhagic stroke and significant gastrointestinal bleeding was not significantly different between the two groups.
Summary
Aspirin did not reduce the risk of atherosclerotic events in patients with type 2 diabetes, without a history of atherosclerotic disease.
Implications
None.
Related Figures
[11]